Summary Of Responsibilities
- Perform the role of the Lead Statistical Programmer.
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs.
- Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards.
- Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective.
- Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes.
- Present and share knowledge at department meetings.
- Respond to QA and client audits and support qualification audits.
- Contribute to proposal activities and participate in bid defenses meetings in order to win new business.
- Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming.
- And all other duties as needed or assigned.
Qualifications (Minimum Required)
- Bachelor's degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
- Experience and/or education plus relevant work experience, equating to a Bachelor's degree.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Language Skills Required: o Speaking: Yes, English required o Writing/Reading: Yes, English required
Experience (Minimum Required)
- Typically, 6 years of SAS programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
- Experience as lead statistical programmer on complex studies in clinical research.
- Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g., Biostatistics and Clinical Data Management.
- Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards.
Physical Demands/Work Environment
- Office or home-based environment, as requested by the line manager.
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